This invention relates generally to the field of arterial and venous catheterization, and more particularly to devices and methods for achieving hemostasis following catheterization.
Catheterization is a fairly common procedure for purposes of diagnosing and treating diseases and other conditions of the human body. Cardiac catheterization is an example of such a procedure. In such a procedure a catheter is inserted into a suitable artery or vein (such as the femoral artery), and then advanced to the proper site inside the human body. After the procedure is completed, the catheter is removed. Bleeding at the puncture site can be a significant medical problem once the catheter is removed, particularly considering the relatively high pressures in the vessels involved. Bleeding at the puncture site can be an even more significant problem when thrombolytic (clot dissolving) agents are used in the procedure. When these agents are used, the patient almost always experiences some type of bleeding problems after removal of the catheter.
Heretofore, standard practice has been to apply direct manual pressure to the puncture site to achieve initial hemostasis and to thereafter apply continuing pressure by means of certain mechanical devices such as bandages, sandbags, or clamps. These particular devices could be improved since they do not adequately localize the applied pressure in the immediate vicinity of the puncture, they are subject to shifting as the patient moves, some tend to be uncomfortable, and many severely limit movement of the patient.
A device called Hold, manufactured by Pressure Products, Inc. and distributed by Cardio Source of Rancho Palos Verdes, California, has been devised to overcome some of these problems, but the Hold device could also be improved. The Hold device uses a foam hemisphere which is placed over the puncture site after initial hemostasis has been achieved. The foam hemisphere is held in place by an elastic strap which, because of its elasticity provides some measure of pressure to the foam hemisphere and the puncture site. Because of the materials involved, however, the actual pressure applied by the Hold device is less than optimal.